Supporting People With Type 2 Diabetes in Effective Use of Their Medicine Through a System Comprising Mobile Health Technology Integrated With Clinical Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 742
- 试验地点
- 2
- 主要终点
- Glycated Hemoglobin (HbA1c) (%)
研究概览
简要总结
This study aims at evaluating the effectiveness of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.
详细描述
A list of patients registered in primary care centers of the Balearic Islands and potentially meeting the eligibility criteria will be obtained from electronic health records (EHRs). A research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. All eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. Participants will be randomly allocated using a computer-generated randomization sequence. All participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. In addition, the intervention group will receive the text messaging intervention. Control participants will receive usual care only.
After twelve months of follow-up, all participants will complete post-intervention assessments via phone interview. Data on glycemic control (HbA1c) at baseline and post-intervention will be extracted from EHRs, as according to the protocol used for primary care providers in the Balearic Islands, patients with poor glycemic control (HbA1c >8% ) must request an HbA1c determination every six months. Results of the most recent determination will be extracted from electronic medical records. For those patients with no recorded HbA1c within the previous four months, the research assistant will contact the primary care center to arrange blood test analyses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Healthcare providers (doctors and nurses from the participants' health centres, do not know if their patients are participating in the study nor the group (intervention vs control) they are. Just if a patient ask them for more information related to the study or text messages, they will know about it. Also, the interviewers that evaluate and register participants data are masked until randomization. After 12 months of follow-up, the interviewers will be masked before post-intervention evaluation. The primary outcome HbA1c is an objective measure and assessors of this outcome will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients registered in the Public Health Service of the Balearic Islands
- •With type 2 diabetes
- •At least one prescription of a glucose-lowering drug
- •With results of HbA1c>8% from 6 months prior to recruitment
排除标准
- •Younger than 18 years old
- •With insulin treatment
- •Participating in another research study
- •Not living in the Balearic Islands at some point during the study development
结局指标
主要结局
Glycated Hemoglobin (HbA1c) (%)
时间窗: Baseline and post-intervention at 12 months
HbA1c was extracted as percentage which is calculated following the standard formulae \[HbA1c(%)=(HbA1c(mmol/mol)+23.5)/ 10.93\] based on its concentration in blood samples. It identifies average plasma glucose concentration (1). The most recent HbA1c data registered between 6th of April and 12th of November in 2021 were extracted for all participants at baseline. At post-intervention, we extracted the most recent data which was available between 21st September 2022 and 21st February 2023.
Mean Adherence to Antidiabetic Drugs (%)
时间窗: Baseline and post-intervention at 12 months
We calculated adherence in terms of medication possession ratio (MPR), defined as the number of days with treatment as medication being dispensed from the pharmacy to the patient (numerator), out of the total days of treatment prescribed by the doctor (denominator) (2): MPR = \[Days with treatment (prescription dispensed) / Days with treatment as prescribed by the doctor\] x 100 At baseline it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 6 months previous to recruitment excluding insulin. At post-intervention it was calculated as the mean adherence for all the glucose lowering drugs prescribed during the 12 months follow-up excluding insulin.
次要结局
- Number of Participants Classified as Adherent Based on Self-reported Adherence to Antidiabetic Medication (7 Items ad Hoc Questionnaire)(Baseline and post-intervention at 12 months)
- Health-related Quality of Life (EQ-5D-5L)(Baseline and post-intervention at 12 months)
- Self-efficacy to Manage Diabetes (DSES-S)(Baseline and post-intervention at 12 months)